THE ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) ACT, 2021 
______________ 

ARRANGEMENT OF SECTIONS 
______________ 

CHAPTER I 

PRELIMINARY 

SECTIONS 

1.  Short title, extent and commencement. 
2.  Definitions. 

CHAPTER II 

AUTHORITIES TO REGULATE ASSISTED REPRODUCTIVE TECHNOLOGY 
A. THE NATIONAL ASSISTED REPRODUCTIVE TECHNOLOGY  
AND SURROGACY BOARD 

3.  National Assisted Reproductive Technology and Surrogacy Board. 

4.  Application of provisions of Surrogacy Act with respect to National Board. 
5.  Powers and functions of National Board. 

B. STATE ASSISTED REPRODUCTIVE TECHNOLOGY AND 

SURROGACY BOARD 

6.  State Assisted Reproductive Technology and Surrogacy Board. 
7.  Application of provisions of Surrogacy Act with respect to State Board. 
8.  Powers and functions of State Board. 

C. THE NATIONAL ASSISTED REPRODUCTIVE TECHNOLOGY AND 
SURROGACY REGISTRY AND THE APPROPRIATE ASSISTED REPRODUCTIVE 
TECHNOLOGY AND SURROGACY AUTHORITY 

9.  Establishment of National Registry of clinics and banks. 

10. Composition of National Registry. 

11. Functions of National Registry. 

12. Appointment of appropriate authority. 

13. Functions of appropriate authority. 

14. Powers of appropriate authority. 

15. Registration of assisted reproductive technology clinic or assisted reproductive technology 

CHAPTER III 
PROCEDURES FOR REGISTRATION 

bank. 

16. Grant of registration. 
17. Renewal of registration. 
18. Suspension or cancellation of registration. 

1 

 
 
 
SECTIONS 

19. Appeal. 

20. Power to inspect premises, etc. 

CHAPTER IV 

DUTIES OF ASSISTED REPRODUCTIVE TECHNOLOGY CLINIC AND ASSISTED REPRODUCTIVE 

TECHNOLOGY BANK 

21. General duties of assisted reproductive technology clinics and banks. 

22. Written informed consent. 

23. Duties of assisted reproductive technology clinics and banks to keep accurate records. 

24. Duties of assisted reproductive technology clinics using human gametes and embryos. 

25. Preimplantation Genetic Diagnosis. 

26. Sex selection.  

27. Sourcing of gametes by assisted reproductive technology banks. 

28. Storage and handling of human gametes and embryos. 

29. Restriction on sale, etc., of human gametes, zygotes and embryos. 

30. Research on human gametes and embryos. 

31. Rights of child born through assisted reproductive technology. 

CHAPTER V 

OFFENCES AND PENALTIES 

32. Sex selective assisted reproductive technology. 

33. Offences and penalties. 

34. Punishment for contravention of provisions of Act or rules for which no specific punishment 

is provided. 

35. Cognizance of offences. 

36. Offences to be cognizable and bailable. 

37. Offences by clinics or banks. 

CHAPTER VI 

MISCELLANEOUS 

38. Power of Central Government to issue directions to National Board, National Registry and 

appropriate authority. 

39. Power of State Government to issue directions to State Board, etc. 

40. Power to search and seize records, etc. 

41. Protection of action taken in good faith. 

42. Power to make rules. 

43. Power to make regulations. 

2 

 
SECTIONS 

44. Laying of rules, regulations and notifications. 

45. Application of other laws not barred. 

46. Power to remove difficulties. 

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
THE ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) ACT, 2021 

ACT NO. 42 OF 2021 

[18th December, 2021.] 

An  Act  for  the  regulation  and  supervision  of  the  assisted  reproductive  technology  clinics  and  the 
assisted reproductive technology banks, prevention of misuse, safe and ethical practice of assisted 
reproductive  technology  services for addressing  the  issues  of  reproductive  health  where assisted 
reproductive  technology  is  required  for  becoming  a  parent  or  for  freezing  gametes,  embryos, 
embryonic tissues for further use due to infertility, disease or social or medical concerns and for 
regulation  and  supervision  of  research  and  development  and  for  matters  connected  therewith  or 
incidental thereto. 

BE it enacted by Parliament in the Seventy-second Year of the Republic of India as follows: — 

CHAPTER I 

PRELIMINARY 

1.  Short  title,  extent  and  commencement.  —  (1)  This  Act  may  be  called  the  Assisted 

Reproductive Technology (Regulation) Act, 2021. 

(2) It shall come into force on such date1 as the Central Government may, by notification in the 

Official Gazette, appoint. 

2. Definitions. — (1) In this Act, unless the context otherwise requires, — 

(a)  “assisted  reproductive  technology”  with  its  grammatical  variations  and  cognate 
expressions, means all techniques that attempt to obtain a pregnancy by handling the sperm or the 
oocyte outside the human body and transferring the gamete or the embryo into the reproductive 
system of a woman;  

(b)  “assisted  reproductive  technology  bank”  means  an  organisation  which  shall  be 
responsible for collection of gametes, storage of gametes and embryos and supply of gametes to 
the assisted reproductive technology clinics or their patients; 

(c)  “assisted  reproductive  technology  clinic”  means  any  premises  equipped  with  requisite 
facilities and medical practitioners registered with the National Medical Commission for carrying 
out the procedures related to the assisted reproductive technology; 

(d)  “child”  means  any  individual  born  through  the  use  of  the  assisted  reproductive 

technology; 

(e)  “commissioning  couple”  means  an  infertile  married  couple  who  approach  an  assisted 
reproductive  technology  clinic  or  assisted  reproductive  technology  bank  for  obtaining  the 
services authorised of the said clinic or bank; 

1. 25th January, 2022, vide notification No. S.O. 291(E), dated 20th January, 2022, see Gazette of India, Extraordinary, Part II, 

sec. 3(ii). 

4 

 
 
 
 
 
 
                                                           
 
(f)  “embryo”  means  a  developing  or  developed  organism  after  fertilisation  till  the  end  of 

fifty-six days from the day of fertilisation; 

(g) “gamete” means sperm and oocyte; 

(h)  “gamete  donor”  means  a  person  who  provides  sperm  or  oocyte  with  the  objective  of 

enabling an infertile couple or woman to have a child; 

(i) “gynaecologist” shall have the same meaning as assigned to it in the Pre-conception and 

Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (57 of 1994); 

(j) “infertility” means the inability to conceive after one year of unprotected coitus or 

other proven medical condition preventing a couple from conception; 

(k) “National Board” means the National Assisted Reproductive Technology and Surrogacy 

Board to be constituted under sub-section (1) of section 17 of the Surrogacy Act; 

(l) “National Registry” means the National Assisted Reproductive Technology and Surrogacy 

Registry established under section 9; 

(m) “notification” means a notification published in the Official Gazette;  

(n)  “patients”  means  an  individual  or  couple  who  comes  to  any  registered  assisted 

reproductive technology clinic for management of infertility;  

(o) “prescribed” means prescribed by rules made under this Act; 

(p) “appropriate authority” means the authority appointed under section 12;  

(q) “regulations” means the regulations made by the National Board under this Act; 

 (r) “sperm” means the mature male gamete;  

(s) “State Board” means a State Assisted Reproductive Technology and Surrogacy Board to 

be constituted under section 26 of the Surrogacy Act;  

(t) “Surrogacy Act” means the Surrogacy (Regulation) Act, 2021; and 

(u)  “woman”  means  any  woman  above  the  age  of  twenty-one  years  who  approaches  an 
assisted reproductive technology clinic or assisted reproductive technology bank for obtaining the 
authorised services of the clinic or bank. 

(2)  The  expressions  “clinics”  and  “banks”  occurring  in  this  Act  shall  be  construed  as  “assisted 

reproductive technology clinics” and “assisted reproductive technology banks”.  

(3) Words and expressions used herein and not defined in this Act but defined in the Surrogacy 

(Regulation) Act shall have the meanings respectively assigned to them in that Act. 

CHAPTER II 

AUTHORITIES TO REGULATE ASSISTED REPRODUCTIVE TECHNOLOGY 

A. THE NATIONAL ASSISTED REPRODUCTIVE TECHNOLOGY 

AND SURROGACY BOARD 

3.  National  Assisted  Reproductive  Technology  and  Surrogacy  Board.  —  The  National 

Assisted  Reproductive  Technology  and  Surrogacy  Board 

to  be  constituted  under                 

5 

 
sub-section  (1)  of  section  17  of  the  Surrogacy  Act  shall  be  the  National  Board  for  the 
purposes of this Act. 

4. Application of provisions of Surrogacy Act with respect to National Board. — Subject to 
the provisions of this Act and the rules made thereunder, the provisions of the Surrogacy Act relating 
to— 

(i) constitution of the National Assisted Reproductive Technology and Surrogacy Board; 

(ii) term of office of Members of the National Board;  

(iii) meetings of the National Board;  

(iv) vacancies, etc., not to invalidate proceedings of the National Board; 

(v) disqualifications for appointment as Member of the National Board;  

(vi) temporary association of persons with the National Board for particular purposes;  

(vii) authentication of orders and other instruments of the National Board; and 

(viii) eligibility of Members of the National Board for re-appointment,  

shall, mutatis mutandis, apply, so far as may be, in relation to assisted reproductive technology as 

they apply in relation to surrogacy, as if they are enacted under this Act. 

5. Powers and functions of National Board. — The National Board shall exercise and discharge 

the following powers and functions, namely:—  

(a) to advise the  Central Government  on  policy  matters  relating  to the assisted  reproductive 

technology;  

(b)  to  review  and  monitor  the  implementation  of  the  Act,  rules  and  regulations  made 

thereunder and recommend to the Central Government, any suitable changes therein;  

(c) to lay down code of conduct to be observed by persons working at clinics and banks, to set 
the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert 
manpower to be employed by clinics and banks;  

(d)  to  oversee  the  performance  of  various  bodies  constituted  under  this  Act  and  take 

appropriate steps to ensure their effective performance;  

(e) to supervise the functioning of the National Registry and liaison with the State Boards;  

(f) to pass orders as per the provisions made under this Act; and  

(g) such other powers and functions as may be prescribed. 

B. STATE ASSISTED REPRODUCTIVE TECHNOLOGY AND SURROGACY BOARD 

6.  State  Assisted  Reproductive  Technology  and  Surrogacy  Board.  —  The  State  Assisted 
Reproductive  Technology  and  Surrogacy  Board  to  be  constituted  under  section 26  of  the  Surrogacy 
Act shall be the State Board for the purposes of this Act. 

7. Application of provisions of Surrogacy Act with respect to State  Board. — Subject to the 
provisions of this Act and the rules made thereunder, the provisions of the Surrogacy Act relating to— 

(i) constitution of the State Assisted Reproductive Technology and Surrogacy Board; 

(ii) composition of the State Board; 

6 

 
(iii) term of office of members of the State Board; 

(iv) meetings of the State Board; 

(v) vacancies, etc., not to invalidate proceedings of the State Board; 

(vi) disqualifications for appointment as member of the State Board; 

(vii) temporary association of persons with the State Board for particular purposes; 

(viii) authentication of orders and other instruments of the State Board; and 

(ix) eligibility of member of the State Board for re-appointment, 

shall, mutatis mutandis, apply, so far as may be, in relation to assisted reproductive technology as they 
apply in relation to surrogacy, as if they are enacted under this Act. 

8. Powers and functions of State Board.— (1) Subject to the provisions of this Act and the rules 
and regulations made thereunder, the State Board shall have the responsibility to follow the policies 
and plans laid by the National Board for clinics and banks in the State. 

(2)  Without  prejudice  to  the  generality  of  the  provisions  contained  in  sub-section  (1),  the  State 
Board,  taking  into  account  the  recommendations,  policies  and  regulations  of  the  National  Board, 
shall—  

(a) co-ordinate the enforcement and implementation of the policies and guidelines for assisted 

reproduction; and  

(b) such other powers and functions as may be prescribed. 

 (3)  In  the  exercise  of  its  functions  under this  Act, the  State  Board  shall  give  such  directions  or 

pass such orders as directed by the National Board. 

C. THE NATIONAL ASSISTED REPRODUCTIVE TECHNOLOGY AND SURROGACY 
REGISTRY AND THE APPROPRIATE ASSISTED REPRODUCTIVE TECHNOLOGY 

 AND SURROGACY AUTHORITY 

9. Establishment of National Registry of clinics and  banks. — The Central Government may, 
within a period of ninety days from the date of commencement of this Act, by notification, establish 
for  the  purposes  of  this  Act  and  Surrogacy  Act,  a  Registry  to  be  called  the  National  Assisted 
Reproductive Technology and Surrogacy Registry. 

10.  Composition  of  National  Registry.  —  The  National  Registry  referred  to  in  section  9  shall 
consist of such scientific, technical, administrative and supportive staff and the terms and conditions of 
their service shall be such as may be prescribed. 

11.  Functions  of  National  Registry.  —  The  National  Registry  shall  discharge  the  following 

functions, namely:— 

(a) it shall act as a central database in the country through which the details of all the clinics 
and banks of the country including nature and types of services provided by them, outcome of the 
services and other relevant information shall be obtained on regular basis; 

(b) it shall assist the National Board in its functioning by providing the data generated from the 

central database of the Registry; 

7 

 
 
(c) the  data  generated  from  the  National  Registry  shall  be  utilised by  the  National  Board for 
making  policies,  guidelines  and  shall  help  in  identifying  new  research  areas  and  conducting 
research in the area of assisted reproduction and other related fields in the country; and  

(d) such other functions as may be prescribed. 

 12.  Appointment  of  appropriate  authority.  —  (1)  The  Central  Government  shall,  within  a 
period of ninety days from the date of commencement of this Act, by notification, appoint one or more 
appropriate assisted reproductive technology and surrogacy authorities for each of the Union territories 
for the purposes of this Act and the Surrogacy Act. 

 (2) The State Government shall, within a period of ninety days from the date of commencement 
of  this  Act,  by  notification,  appoint  one  or  more  appropriate  assisted  reproductive  technology  and 
surrogacy  authorities  for  the  whole  or  any  part  of  the  State  for  the  purposes  of  this  Act  and  the 
Surrogacy Act.  

(3) The appropriate authority, under sub-section (1) or sub-section (2), shall, —  

(a) when appointed for the whole of the State or the Union territory, consist of—  

(i) an officer of or above the rank of the Joint Secretary of the Health and Family Welfare 

Department—Chairperson, ex officio; 

(ii) an officer of or above the rank of the Joint Director of the Health and Family Welfare 

Department — Vice Chairperson, ex officio;  

(iii) an eminent woman representing women's organisation—member;  

(iv) an officer of Law Department of the State or the Union territory concerned not below 

the rank of a Deputy Secretary—member, ex officio; and 

 (v) an eminent registered medical practitioner—member: 

Provided  that  any  vacancy  occurring  therein  shall  be  filled  within  one  month  of  the 

occurrence of such vacancy;  

(b) when appointed for any part of the State or the Union territory, the officers of such other 

rank as the State Government or the Central Government, as the case may be, may deem fit.  

(4)  The  members  of  appropriate  authority,  other  than  ex  officio  members,  shall  receive  only 

compensatory travelling expenses for attending the meetings of such Authority. 

13.  Functions  of  appropriate  authority.  —The  appropriate  authority  shall  discharge  the 

following functions, namely: —  

(a) to grant, suspend or cancel registration of a clinic or bank;  

(b) to enforce the standards to be fulfilled by the clinic or bank;  

(c)  to  investigate  complaints  of  breach  of  the  provisions  of  this  Act,  rules  and  regulations 

made thereunder and take legal action as per provisions of this Act;  

(d) to take appropriate legal action against the misuse of assisted reproductive technology by 

any person and also to initiate independent investigations in such matter;  

(e) to supervise the implementation of the provisions of this Act and the rules and regulations 

made thereunder;  

8 

 
(f) to recommend to the National Board and State Boards about the modifications required in 

the rules and regulations in accordance with changes in technology or social conditions; 

(g)  to  take  action  after  investigation  of  complaints  received  by  it  against  the  assisted 

reproductive technology clinics or banks; and  

(h) such other functions as may be prescribed. 

14. Powers of appropriate authority. —(1) The appropriate authority shall exercise the powers 

in respect of the following matters, namely:—  

(a) summoning of any person who is in possession of any information relating to violation of 

the provisions of this Act and the rules and regulations made thereunder;  

(b) production of any document or material object relating to clause (a); 

(c) searching of any place suspected to be violating the provisions of this Act and the rules and 

regulations made thereunder; and  

(d) such other powers as may be prescribed. 

 (2)  The  appropriate  authority  shall  maintain  the  details  of  registration  of  assisted  reproductive 
technology clinics and banks, cancellation of registration, renewal of registration, grant of certificates 
to the commissioning couple and woman or any other matter pertaining to grant of licence and the like 
of the clinic or bank in such format as may be prescribed and submit the same to the National Board. 

CHAPTER III 

PROCEDURES FOR REGISTRATION 

15.  Registration  of  assisted  reproductive  technology  clinic  or  assisted  reproductive 
technology  bank.  —  (1)  No  person  shall  establish  any  clinic  or  bank  for  undertaking  assisted 
reproductive technology or to render assisted reproductive technology procedures in any form unless 
such clinic or bank is duly registered under this Act. 

 (2) Every application for registration under sub-section (1) shall be made to the National Registry 
through  the  appropriate  assisted  reproductive  technology  and  surrogacy  authority  in  such  form, 
manner and shall be accompanied by such fees as may be prescribed.  

(3)  Every  clinic  or  bank  which  is  conducting  assisted  reproductive  technology,  partly  or 
exclusively shall, within a period of sixty days from the date of establishment of the National Registry, 
apply for registration: 

 Provided that such clinics and banks shall cease to conduct any such counselling or procedures on 
the expiry of six months from the date of commencement of this Act, unless such clinics and banks 
have  applied  for  registration  and  is  so  registered  separately  or  till  such  application  is  disposed  of, 
whichever is earlier.  

(4)  No  clinics  or  banks  shall  be  registered  under  this  Act,  unless  the  appropriate  authority  is 
satisfied  that  such  clinics  and  banks  are  in  a  position  to  provide  such  facilities  and  maintain  such 
equipment  and  standards  including  specialised  manpower,  physical  infrastructure  and  diagnostic 
facilities as may be prescribed. 

16. Grant of registration. — (1) On receipt of the application under sub-section (1) of section 15, 

the appropriate authority shall within a period of thirty days—  

9 

 
(i) grant registration subject to the provisions of this Act and the rules and regulations made 

thereunder, and provide a registration number to the applicant; or 

(ii)  reject  the  application  for  reasons  to  be  recorded  in  writing,  if  such  application  does  not 

conform to the provisions of this Act or the rules or regulations made thereunder:  

Provided  that  no  application  shall  be  rejected  unless  the  applicant  has  been  given  an 

opportunity of being heard in the matter.  

(2) If the appropriate authority fails to grant the registration or reject the application,  as the case 
may  be,  as  provided  under  sub-section  (1),  the  appropriate  authority  shall,  within  a  period  of  seven 
days from the expiry of the said period of thirty days specified under sub-section (1), provide a reason 
for the failure to process the application. 

(3)  The  appropriate  authority  shall,  within  a  period  of  one  month  of  registration  being  granted 

under this section, intimate such registration to the State Board. 

(4) The State Board shall maintain a record of all registrations applied for and granted under this 

section.  

(5)  No  registration  shall  be  granted  unless  the  State  Board  has  inspected  the  premises  of  the 

applicant. 

(6) The  registration  granted  under  this  section shall be  valid for a  period  of five  years  from  the 

date of registration granted by the appropriate authority.  

(7) The certificate of registration shall be displayed by the clinic or bank at a conspicuous place 

and such certificate shall contain the duration of validity of such registration. 

17. Renewal of registration. — The registration granted under section 16, may be renewed for a 
further  period  of  five  years  by  the  appropriate  authority,  on  an  application  made  by  the  applicant, 
under such conditions, in such form and on payment of such fee as may be prescribed: 

Provided  that  no  application  for  renewal  of  registration  shall  be  rejected  without  giving  an 

opportunity of being heard to the applicant. 

18.  Suspension or cancellation of registration. — (1) The appropriate authority may on receipt 
of a complaint, issue a notice to the clinic or bank to show cause as to why its registration should not 
be suspended or cancelled for the reasons mentioned in the notice.  

(2)  If  after  giving  a  reasonable  opportunity  of  being heard  to  the clinic  or  bank,  the  appropriate 
authority is satisfied that there has been a breach of the provision of this Act or the rules or regulations 
made  thereunder  or if the data obtained  from  them  periodically  do  not satisfy  the  provisions  of this 
Act,  the  rules  and  regulations  made  thereunder,  it  may,  without  prejudice  to  any  criminal  action, 
suspend its registration for such period as it may deem fit or cancel its registration.  

(3) On cancellation of registration, a copy of the cancellation letter shall be sent to the respective 

State Board and accordingly the State Board shall cancel the registration of such clinics and banks. 

19.  Appeal.  —  The  clinic  or  bank  or  the  commissioning  couple  or  the  woman  may,  within  a 
period  of  thirty  days  from  the  date  of  receipt of the communication  relating  to order  of  rejection  of 
application,  suspension  or  cancellation  of  registration  passed  by  the  appropriate  authority  under 
section 16 or section 18, prefer an appeal against such order to—  

10 

 
(a) the  State  Government, where the  appeal  is  against  the  order  of  the  appropriate authority     

of a State; 

(b) the Central Government, where the appeal is against the order of the appropriated authority 

of a Union territory,  

in such manner as may be prescribed.  

20.  Power  to  inspect  premises,  etc.— The National Board, the National Registry and the State 

Board shall have the power to, —  

(i) inspect, any premises relating to assisted reproductive technology; or 

(ii) call for any document or material, 

in exercise of their powers and discharge of their functions.  

CHAPTER IV 

DUTIES OF ASSISTED REPRODUCTIVE TECHNOLOGY CLINIC AND ASSISTED 

REPRODUCTIVE TECHNOLOGY BANK 

21. General duties of assisted reproductive technology clinics and  banks. — The clinics and 

banks shall perform the following duties, namely:—  

(a)  the  clinics  and  banks  shall  ensure  that  commissioning  couple,  woman  and  donors  of 
gametes  are  eligible  to  avail  the  assisted  reproductive  technology  procedures  subject  to  such 
criteria as may be prescribed; 

(b) the clinics shall obtain donor gametes from the banks and such banks shall ensure that the 

donor has been medically tested for such diseases as may be prescribed;  

(c) the clinics shall— 

 (i)  provide  professional  counselling  to  commissioning  couple  and  woman  about  all  the 
implications  and  chances  of  success  of  assisted  reproductive  technology  procedures  in  the 
clinic;  

(ii)  inform  the  commissioning  couple  and  woman  of  the  advantages,  disadvantages  and 
cost  of  the  procedures,  their  medical  side  effects,  risks  including  the  risk  of  multiple 
pregnancy; and  

(iii) help the commissioning couple or woman to arrive at an informed decision on such 

matters that would most likely be the best for the commissioning couple;  

(d) the clinics shall make commissioning couple or woman, aware of the rights of a child born 

through the use of assisted reproductive technology; 

(e)  the  clinics  and  banks  shall  ensure  that  information  about  the  commissioning  couple, 
woman  and  donor  shall  be  kept  confidential  and  the  information  about  treatment  shall  not  be 
disclosed to anyone except to the database to be maintained by the National Registry, in a medical 
emergency at the request of the commissioning couple to whom the information relates, or by an 
order of a court of competent jurisdiction; 

(f) every clinic and every bank shall maintain a grievance cell in respect of matters relating to 
such clinics and banks and the manner of making a compliant before such grievance cell shall be 
such as may be prescribed; 

11 

 
(g) the clinics shall apply the assisted reproductive technology services, —  

(i) to a woman above the age of twenty-one years and below the age of fifty years;  

(ii) to a man above the age of twenty-one years and below the age of fifty-five years; 

(h) the clinics shall issue to the commissioning couple or woman a discharge certificate stating 
details of the assisted reproductive technology procedure performed on the commissioning couple 
or woman; 

(i)  all  clinics  and  banks  shall  co-operate  and  make  available  their  premises  for  physical 

inspection by the National Board, National Registry and State Boards;  

(j) all clinics and banks shall provide all information related to—  

(i) enrolment of the commissioning couple, woman and gamete donors; 

 (ii) the procedure being undertaken; and 

 (iii)  outcome  of  the  procedure,  complications,  if  any,  to  the  National  Registry 

periodically, in such manner as may be prescribed. 

22.  Written  informed  consent.  —  (1) The  clinic  shall  not  perform  any  treatment  or  procedure 

without— 

(a) the written informed consent of all the parties seeking assisted reproductive technology;  

(b) an insurance coverage of such amount as may be prescribed for a period of twelve months 
in favour of the oocyte donor by the commissioning couple or woman from an insurance company 
or an agent recognised by the Insurance Regulatory and Development Authority established under 
the provisions of the Insurance Regulatory and Development Authority Act, 1999 (41 of 1999). 

 (2) The clinics and banks shall not cryo-preserve any human embryos or gamete, without specific 
instructions  and  consent  in  writing  from  all  the  parties  seeking  assisted  reproductive  technology,  in 
case of death or incapacity of any of the parties.  

(3)  The  clinic  shall  not  use  any  human  reproductive  material,  except  in  accordance  with  the 
provisions  of  this  Act  to  create  a  human  embryo  or  use  an  in-vitro  human  embryo  for  any  purpose 
without the specific consent in writing of all the concerned persons to whom the assisted reproductive 
technology relates.  

(4) Any of the commissioning couple may withdraw his or her consent under sub-section (1), any 

time before the human embryos or the gametes are transferred to the concerned woman's uterus.  

Explanation. —For the purposes of this section, the expressions— 

(i) “cryo-preserve” means the freezing and storing of gametes, zygotes, embryos, ovarian and 

testicular tissues; 

(ii)  “insurance”  means  an  arrangement  by  which  a  company,  individual  or  commissioning 
couple undertake to provide a guarantee of compensation for specified loss, damage, complication 
or death of oocyte donor during the process of oocyte retrieval; and  

(iii) “parties” includes the commissioning couple or woman and the donor. 

23. Duties of assisted reproductive technology clinics and banks to keep accurate records. — 
The  duties  of  clinics  and  banks  while  keeping  the  records  relating  to  such  clinics  and  banks  are  as 
under:— 

12 

 
(a)  all  clinics  and  banks  shall  maintain  detailed  records  of  all  donor’s  oocytes,  sperm  or 
embryos  used  or  unused,  the  manner  and  technique  of  their  use  in  such  manner  as  may  be 
prescribed;  

(b)  all  clinics  and  banks  shall,  as  and  when  the  National  Registry  is  established,  submit  by 

online, —  

(i) all information available with them in regard to progress of the commissioning couple 

or woman; and  

(ii)  information  about  number  of  donors  (sperm  and  oocyte),  screened,  maintained  and 
supplied and the like to the National Registry within a period of one month from the date of 
receipt of such information;  

(c)  the  records  maintained  under  clause  (a)  shall  be  maintained  for  at  least  a  period  of  ten 
years, upon the expiry of which the clinic and bank shall transfer the records to a central database 
of the National Registry:  

Provided that if any criminal or other proceedings are instituted against any clinics or banks, 
the  records  and  all  other  documents  of  such  clinics  and  banks  shall  be  preserved  till  the  final 
disposal of such proceedings;  

(d) in the event of the closure of any clinic or bank before the expiry of the period of ten years 
under clause (c), such clinic or bank shall immediately transfer the records to the central database 
of the National Registry; and  

(e)  all  such  records  shall,  at  all  reasonable  times,  be  made  available  for  inspection  to  the 
National Board or the National Registry or the State Board or to any other person authorised by 
the National Board in this behalf. 

24. Duties of assisted reproductive technology clinics using human gametes and embryos. — 
While using human gametes and embryos, the duties to be performed by the clinics and banks shall be 
as under:— 

(a) the clinics shall retrieve oocytes in such manner as may be specified by regulations; 

(b) not more than three oocytes or embryos may be placed in the uterus of a woman during the 

treatment cycle in such manner as may be specified by regulations; 

(c) a woman shall not be treated with gametes or embryos derived from more than one man or 

woman during any one treatment cycle;  

(d) a clinic shall never mix semen from two individuals for the procedures specified under this 

Act; 

(e) the embryos shall not be split and used for twinning to increase the number of available 

embryos; 

(f)  the  collection  of  gametes  posthumously  shall  be  done  only  if  prior  consent  of  the 

commissioning couple is available in such manner as may be prescribed;  

(g)  the  clinic  shall  not  use  ovum  that  are  derived  from  a  foetus,  in  any  process  of  in-vitro 

fertilisation; and 

(h) such other duties as may be prescribed.  

13 

 
Explanation.—For the purposes of this section, the expression— 

(i)  “fertilisation”  means  the  penetration  of  the  ovum  by  the  spermatozoon  and  fusion of 

genetic materials resulting in the development of a zygote; and  

(ii) “foetus” means a human organism during the period of its development beginning on 

the fifty-seventh day following fertilisation and ending at birth or abortion. 

25. Preimplantation Genetic Diagnosis. —(1) The Pre-implantation Genetic testing shall be used 

to screen the human embryo for known, pre-existing, heritable or genetic diseases only. 

 (2) The donation of an embryo after Pre-implantation Genetic Diagnosis to an approved research 

laboratory for research purposes shall be done only— 

 (a) with the approval of the commissioning couple or woman; and 

 (b) when the embryo suffers from pre-existing, heritable, life-threatening or genetic diseases.  

(3) The National Board may lay down such other conditions as it deems fit in the interests of the 

Pre-implantation Genetic testing.  

Explanation.—For the purposes of this section, the expression— 

(i)  “Pre-implantation  Genetic  Diagnosis”  means  the  genetic  diagnosis  when  one  or  both 
genetic  parents  has  a  known  genetic  abnormality  and  testing  is  performed  on  an  embryo  to 
determine if it also carries a genetic abnormality; and 

(ii)  “Pre-implantation  Genetic testing”  means  a  technique  used to identify  genetic defects in 

embryos created through in-vitro fertilisation before pregnancy. 

26. Sex selection.— (1) Subject to the provisions of the Pre-conception and Pre-natal Diagnostic 
Techniques (Prohibition of Sex Selection) Act, 1994, (57 of 1994) the clinic shall not offer to provide 
a couple or woman with a child of a pre-determined sex. 

 (2) It is prohibited for anyone to do any act, at any stage, to determine the sex of the child to be 
born through the process of assisted reproductive technology to separate, or yield fractions enriched in 
sperm of X or Y variations. 

(3)  A  person  shall  not  knowingly  provide,  prescribe  or  administer  anything  that  shall  ensure  or 
increase the probability that an embryo shall be of a particular sex, or that shall identify the sex of an 
in-vitro embryo, except to diagnose, prevent or treat a sex-linked disorder or disease. 

27.  Sourcing  of  gametes  by  assisted reproductive technology  banks.  — (1) The screening of 
gamete donors, the collection, screening and storage of semen; and provision of oocyte donor, shall be 
done only by a bank registered as an independent entity under the provisions of this Act. 

(2) The banks shall—  

(a) obtain semen from males between twenty-one years of age and fifty-five years of age, both 

inclusive; 

(b)  obtain  oocytes  from  females  between  twenty-three  years  of  age  and  thirty-five  years  of 

age; and 

(c) examine the donors for such diseases, as may be prescribed. 

(3) A bank shall not supply the sperm or oocyte of a single donor to more than one commissioning 

couple.  

14 

 
(4)  An  oocyte  donor  shall donate  oocytes  only  once  in  her life  and  not  more  than  seven  oocyte 

shall be retrieved from the oocyte donor.  

(5) All unused oocytes shall be preserved by the banks for use on the same recipient, or given for 
research  to  an  organisation  registered  under  this  Act  after  seeking  written  consent  from  the 
commissioning couple.  

(6) A bank shall  obtain all necessary information in  respect  of a sperm or oocyte donor, 
including  the  name,  Aadhaar  number  as  defined  in  clause  (a)  of  section  2  of  the  Aadhaar 
(Targeted  Delivery  of  Financial  and  other  Subsidies,  Benefits  and  Services)  Act,  2016, 
address and any other details of such donor, in such manner as may be prescribed, and shall 
undertake in writing from such donor about the confidentiality of such information. 

Explanation. —For the purposes of this section, the expressions— 

(i) “retrieval” means a procedure of removing oocytes from the ovaries of a woman;  

(ii)  “screening”  means  the  genetic  test  performed  on  embryos  produced  through  in-vitro 

fertilisation. 

28. Storage and handling of human gametes and embryos. — (1) The standards for the storage 
and  handling  of  gametes, gonadal tissues and  human  embryos  in respect  of their  security,  recording 
and identification shall be such as may be prescribed. 

(2) The gamete of a donor or embryo shall be stored for a period of not more than ten years and at 
the end of such period such gamete or embryo shall be allowed to perish or be donated to a  research 
organisation  registered  under  this  Act  for  research  purposes  with  the  consent  of  the  commissioning 
couple or individual, in such manner as may be prescribed. 

29. Restriction on sale, etc., of human gametes, zygotes and embryos. — The sale, transfer or 
use  of  gametes,  zygotes  and  embryos,  or  any  part  thereof  or  information  related  thereto,  directly  or 
indirectly to any party within or outside India shall be prohibited except in the case of transfer of own 
gametes and embryos for personal use with the permission of the National Board.  

Explanation.  —For  the  purposes  of  this  section,  the  expression  “zygote”  means  the  fertilised 

oocyte prior to the first cell division. 

30.  Research  on  human  gametes  and  embryos.  —  (1)  The  use  of  any  human  gametes  and 

embryos or their transfer to any country outside India for research shall be absolutely prohibited. 

(2) The research on human gamete or embryo within India shall be performed in such manner as 

may be prescribed. 

31.  Rights  of  child  born  through  assisted  reproductive  technology.  —  (1)  The  child  born 
through  assisted  reproductive  technology  shall  be  deemed  to  be  a  biological  child  of  the 
commissioning couple and the said child shall be entitled to all the rights and privileges available to a 
natural child only from the commissioning couple under any law for the time being in force.  

(2) A donor shall relinquish all parental rights over the child or children which may be born from 

his or her gamete. 

15 

 
 
 
 
CHAPTER V 

OFFENCES AND PENALTIES 

32.  Sex  selective  assisted  reproductive  technology.  —  (1)  The  clinic,  or  bank  or  agent 
thereof,  shall  not  issue,  publish,  distribute,  communicate  or  cause  to  be  issued,  published, 
distributed  or  communicated  any  advertisement  in  any  manner  including  internet,  regarding 
facilities of sex selective assisted reproductive technology.  

(2)  Whoever  contravenes  the  provisions  of  sub-section  (1)  shall  be  punishable  with 
imprisonment for a term which shall not be less than five years but may extend to ten years or 
with fine which shall not be less than ten lakh rupees but may extend to twenty-five lakh rupees 
or with both. 

33. Offences and penalties. — (1) Any medical geneticist, gynaecologist, registered medical 

practitioner or any person shall not—  

(a) abandon, disown or exploit or cause to be abandoned, disowned or exploited in any 

form the child or children born through assisted reproductive technology; 

(b)  sell  human  embryos  or  gametes,  run  an  agency,  a  racket  or  an  organisation  for 

selling, purchasing or trading in human embryos or gametes; 

(c)  import  or  help  in  getting  imported  in  whatsoever  manner,  the  human  embryos  or 

human gametes;  

(d) exploit the commissioning couple, woman or the gamete donor in any form;  

(e) transfer human embryo into a male person or an animal;  

(f) sell any human embryo or gamete for the purpose of research; or  

(g) use any intermediates to obtain gamete donors or purchase gamete donors.  

(2)  Whoever  contravenes  the  provisions  of  clauses  (a)  to  (g)  of  sub-section  (1),  shall  be 
punishable with a fine which shall not be less than five lakh rupees but may extend to ten lakh 
rupees  for  the  first  contravention  and  for  subsequent  contravention,  shall  be  punishable  with 
imprisonment for a term which shall not be less than three years but may extend to eight years 
and with fine which shall not be less than ten lakh rupees but may extend to twenty lakh rupees. 

34.  Punishment  for  contravention  of  provisions  of  Act  or  rules  for  which  no  specific 
punishment  is  provided.  —  Whoever  contravenes  any  of  the  provisions  of  this  Act  or  any 
rules made thereunder, for which no penalty has been provided in this Act shall be punishable 
as per sub-section (2) of section 33. 

35. Cognizance of offences. — (1) No court shall take cognizance of any offence punishable 
under this Act, save on a complaint made by the National  Board or the State Board or by an 
officer authorised by it.  

(2) No court inferior to that of a Metropolitan Magistrate or a Judicial Magistrate of the first 

class shall try any offence punishable under this Act. 

36. Offences to be cognizable and bailable. — Notwithstanding anything contained in the 
Code  of  Crimincal  Procedure,  1973  (2  of  1974),  all  the  offences  under  this  Act  shall  be 
cognizable and bailable. 

16 

 
37.  Offences  by  clinics  or  banks.—  (1)  Where  an  offence  under  this  Act  has  been 
committed by any clinic or bank, the executive head of such clinic or bank shall be deemed to 
be  guilty  of  an  offence  and  shall  be  liable  to  be  proceeded  against  and  punished  accordingly 
unless  he  proves  that  the  offence  was  committed  without  his  knowledge  or  that  he  had 
exercised all due diligence to prevent the commission of such offence. 

(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act 
has been committed by any clinic or bank and it is proved that the offence has been committed 
with the consent or connivance of, or is attributable to any neglect on the part of any officer, 
other  than  the  executive  head  of  the  clinic  or  bank,  such  officer  shall  also  be  deemed  to  be 
guilty of that offence and shall be liable to be proceeded against and punished accordingly. 

CHAPTER VI 

MISCELLANEOUS 

38.  Power  of  Central  Government  to  issue  directions  to  National  Board,  National 
Registry  and  appropriate  authority.—(1) The Central  Government may,  from  time to  time 
issue to the National Board, the National Registry and the appropriate authority with respect to 
the Union territory, such directions as it may think necessary in the interest of the sovereignty 
and integrity of India, security of the State, friendly relation with foreign States, public order, 
decency or morality.  

(2)  Without  prejudice  to  the  foregoing  provisions  of  this  Act,  the  National  Board,  the 
National  Registry  and  the  appropriate  authority  shall,  in  exercise  of  its  powers  or  the 
performance of its functions under this Act, be bound by such directions on questions of policy 
as the Central Government or the State Government, as the case may be, may give in writing to 
it from time to time: 

 Provided  that  the  National  Board  shall,  as  far  as  practicable,  be  given  an  opportunity  to 

express its views before any direction is given under sub-section (1).  

(3)  If  any  dispute  arises  between  the  Central  Government  and  the  National  Board  as  to 
whether  a  question  is  or  is  not  a  question  of  policy,  the  decision  of  the  Central  Government 
shall be final. 

39. Power of State  Government  to issue directions to State Board, etc.— (1) The State 
Government may, from time to time issue to the State Board and to the appropriate authority 
with respect to the State Government such directions as it may think necessary in the interest of 
the sovereignty and integrity of India, security of the State, friendly relation with foreign States, 
public order, decency or morality.  

(2)  Without  prejudice  to  the  foregoing  provisions  of  this  Act,  the  State  Board  and  the 
appropriate authority shall, in exercise of its powers or the performance of its functions under 
this Act, be bound by such directions on questions of policy as the State Government may give 
in writing to it from time to time: 

Provided  that  the  State  Board  and  the  appropriate  authority  shall,  as  far  as  practicable,  be 

given an opportunity to express its views before any direction is given under sub-section (1). 

17 

 
 
(3) If any dispute arises between the State Government and the State Board as to whether a 

question is or is not a question of policy, the decision of the State Government shall be final. 

40.  Power  to  search  and  seize  records,  etc.—(1)  If  the  National  Board,  the  National 
Registry or the State Board has reason to believe that an offence under this Act has been or is 
being  committed  at  any  facility  using  assisted  reproductive  technology,  such  Board  or  any 
officer  authorised  in  this  behalf  may,  subject  to  such  rules  as  may  be  prescribed,  enter  and 
search at all reasonable times with such assistance, if any, as such Board or officer considers 
necessary,  such  facility  using  assisted  reproductive  technology  and  examine  any  record, 
register,  document,  book,  pamphlet,  advertisement  or  any  other  material  object  found  therein 
and seize the same, if the said Board has reason to believe that it may furnish evidence of the 
commission of an offence punishable under this Act.  

(2) The provisions of the Code of Criminal Procedure, 1973 (2 of 1974), relating to searches 

and seizures shall, so far as may be, apply to every search or seizure made under this Act. 

41.  Protection  of  action  taken  in  good  faith.—  No  suit,  prosecution  or  other  legal 
proceeding shall lie against  the Central  Government  or the State Government  or the National 
Board  or  the  National  Registry  or  the  State  Board  or  the  appropriate  authority  or  any  other 
officer authorised by the Central Government or the State Government or the National Board or 
the National Registry or the State Board or the appropriate authority for anything which is done 
in good faith or intended to be done in pursuance of the provisions of this Act or the  rules or 
regulations made thereunder. 

42. Power  to  make  rules.  — (1) The Central Government may by notification make rules 

for carrying out the provisions of this Act. 

(2) In particular, and without prejudice to the generality of the foregoing power, such rules 

may provide for—  

(a) the other powers and functions of the National Board under clause (g) of section 5; 

(b) the other powers and functions of the State Board under clause (b) of sub-section (2) 

of section 8;  

(c) the terms of office and other conditions of service of scientific, technical and other 

employees of the National Registry under section 10;  

(d) the other functions of the National Registry under clause (d) of section 11;  

(e) the other functions of the appropriate authority under clause (h) of section 13;  

(f)  the  other  powers  to  be  exercised  by  the  appropriate  authority  under  clause  (d)  of          

sub-section (1) of section 14;  

(g) the format for granting of licences to the clinic or bank by the appropriate authority 

under sub-section (2) of section 14;  

(h) the form and manner in which an application shall be made for registration and fee 

payable thereof under sub-section (2) of section 15;  

(i) the facilities and equipments to be provided and maintained by the clinics and banks 

under sub-section (4) of section 15;  

18 

 
(j) the conditions, form and fee for application of renewal of the registration of clinic or 

bank under section 17;  

(k)  the  manner  in  which  an  appeal  may  be  preferred  to  the  State  Government  or  the 

Central Government under section 19;  

(l)  the  criteria  for  availing  the  assisted  reproductive  technology  procedures  under     

clause (a) of section 21; 

(m)  the  medical  examination  of  the  diseases  with  respect  to  which  the  donor  shall  be 

tested under clause (b) of section 21; 

(n)  the  manner  of  making  a  complaint  before  a  grievance  cell  and  the  mechanism 

adopted by the clinic under clause (f) of section 21; 

(o)  the  manner  of  providing  information  by  the  clinics  and  banks  to  the  National 

Registry under clause (j) of section 21;  

(p)  the  amount  of  insurance  coverage  for  oocyte  donor  under  clause  (b)  of                 

sub-section (1) of section 22;  

(q) the manner of maintaining the records by the clinics and banks under clause (a) of 

section 23;  

(r) the manner of collection of gametes posthumously under clause (f) of section 24;  

(s) the other duties of clinics under clause (h) of section 24;  

(t)  the  examination  of  the  donors  by  the  assisted  reproductive  technology  banks  for 

diseases under clause (c) of sub-section (2) of section 27; 

(u) the manner of obtaining information in respect of a sperm or oocyte donor by a bank 

under sub-section (6) of section 27;  

(v) the standards for the storage and handling of gametes, human embryos in respect of 

their security, recording and identification under sub-section (1) of section 28; 

(w) the manner of obtaining the consent of the commissioning couple or individual for 
perishing or donating the gametes of a donor or embryo under sub-section (2) of section 28;  

(x) the manner of performing research on human gametes or embryo within India under 

sub-section (2) of section 30;  

(y) the manner of entry and search by the National Board, the National Registry or the 

State Board or any officer authorised by it under sub-section (1) of section 40;  

(z)  any  other  matter  which  is  to  be,  or  may  be  prescribed,  or  in  respect  of  which 

provision is to be made by rules. 

43.  Power to make regulations. — (1) The National Board may, with the prior approval of 
the Central Government, by notification make regulations consistent with this Act and the rules 
made thereunder to carry out the provisions of the Act; 

 (2)  In  particular,  and  without  prejudice  to  the  generality  of  the  foregoing  power,  such 

regulations may provide for—  

(a) the manner of retrieving the oocytes under clause (a) of section 24;  

19 

 
(b)  the  manner  of  placing  the  oocytes  or  embryos  in  the  uterus  of  a  woman  under          

clause (b) of section 24; and  

(c)  any  other  matter  which  is  required  to  be,  specified  by  regulations  or  in  respect  of 

which provision is to be made by regulations. 

44.  Laying  of  rules,  regulations  and  notifications.—  Every  rule  or  regulation  made  and 
notification  issued  under  this  Act  shall  be  laid,  as  soon  as  may  be  after  it  is  made  or  issued, 
before each House of Parliament, while it is in session, for a total period of thirty days which 
may  be  comprised  in  one  session  or  in  two  or  more  successive  sessions,  and  if,  before  the 
expiry  of  the  session  immediately  following  the  session  or  the  successive  sessions  aforesaid, 
both Houses agree in making any modification in the rules or regulations or notifications, as the 
case may be or both Houses agree that the rules or regulations or notifications, as the case may 
be, should not be made or issued, such rules or regulations or notifications, as the case may be, 
shall thereafter have effect only in such modified form or be of no effect, as the case may be; 
so, however, that any such modification or annulment shall be without prejudice to the validity 
of anything previously done under that rule or regulation or notification, as the case may be. 

45.  Application  of  other  laws  not  barred.  —  The  provisions  of  this  Act  shall  be  in 
addition  to,  and  not  in  derogation  of,  the  provisions  of  the  Pre-conception  and  Pre-natal 
Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (57 of 1994) and the Clinical 
Establishment (Registration and Regulation) Act,  2010 (23 of 2010) or of any other law for 
the time being in force. 

46.  Power  to  remove  difficulties.  —  (1)  If  any  difficulty  arises  in  giving  effect  to  the 
provisions  of  this  Act,  the  Central  Government  may,  by  order  published  in  the  Official 
Gazette, make such provisions not inconsistent with the provisions of this Act as may appear 
to it to be necessary or expedient for removing the difficulty: 

Provided that no such order shall be made after the expiry of a period of three years from 

the date of commencement of this Act.  

(2) Every order made under this section shall, as soon as may be made, be laid before each 

House of Parliament.  

20 

 
 
